EP0854735A1

EP0854735A1 - Needleless jet injection device comprising a moulded-on cartridge

Info

Publication number: EP0854735A1
Application number: EP96933507A
Authority: EP
Inventors: Alain Moreau Defarges; Xavier Moreau Defarges
Original assignee: Individual
Current assignee: Individual
Priority date: 1995-10-09
Filing date: 1996-10-09
Publication date: 1998-07-29
Anticipated expiration: 2016-10-09
Also published as: AU7221296A; JPH11513291A; CA2234482A1; FR2739562B1; DE69607364T2; EP0854735B1; BR9611034A; ES2146904T3; US6053890A; JP4003816B2; WO1997013536A1; ATE190851T1; CN1199345A; FR2739562A1; DE69607364D1

Abstract

PCT No. PCT/FR96/01573 Sec. 371 Date Aug. 31, 1998 Sec. 102(e) Date Aug. 31, 1998 PCT Filed Oct. 9, 1996 PCT Pub. No. WO97/13536 PCT Pub. Date Apr. 17, 1997A needleless jet injection device including a barrel fitted with a cap at one of the ends thereof. Relative motion of the cap component actuates a setting device operably connected to a precussive member. A cartridge arranged at the other end of the barrel comprises two elements, i.e., a first element forming a container for the active principle, and a second element consisting of a plastic shell enclosing the first element.

Description

"Needle-less jet injection device, comprising an overmolded cartridge"

The present invention relates to a device for injecting a product, in particular a pharmaceutical product, into the human or animal body.

It relates more particularly to a device devoid of hypodermic needle, equipped with an arming system, which authorizes the administration by subcutaneous, intradermal or intramuscular route, of medicinal or vaccine substances, contained in a dose, for single use , forming a cartridge.

There are known needleless transcutaneous jet injection devices which have been developed for veterinary or human medicine. The absence of a needle simplifies the use of the device and does not require specific knowledge of the user. They are generally used for massive vaccination campaigns and are designed so that they can be implemented quickly by non-specialist personnel. The use of a jet minimizes bacterial and / or viral contamination from one subject to another, which occurred in cases where the same needle is used without sterilization by several subjects. These devices are generally compliant in the form of a gun, equipped with a container of product to be injected, conveyed through a nozzle, by the action of a piston moving in a chamber, previously filled with the substance, the piston being moved by a striker. Alternatively, the pistol comprises a breech or magazine containing a cartridge also placed in the axis of the striker.

Taking into account the mode of action of the striker which has a significant kinetic energy before reaching the piston of the cartridge which can, in the case where the cartridge is not correctly arranged in the magazine of the gun, cause its bursting at the start injection, these devices are not reliable and are not easy to use for use that does not fall under frequent use.

The present invention therefore aims to remedy these drawbacks, by proposing a device devoid of a cartridge magazine and allowing injection by needle-free jet of product contained in a cartridge directly placed at the head of said device, under rigorous aseptic conditions, for individual use.

To this end, the needleless jet injection device, comprising a body receiving at one of its ends a cap which can, thanks to a relative movement between these elements, drive an arming device, cooperating with a percussion, is characterized in that there is at the other end of the body of said device, a cartridge comprising two elements:

- The first element makes the container to contain the active ingredient;

- The second element is constituted by a plastic envelope which covers said first element.

Other characteristics and advantages of the present invention will emerge from the description given below, with reference to the accompanying drawings which illustrate an exemplary embodiment thereof without any limiting character. In the figures: - Figure 1 is a plan view, in front elevation and in section, of the device according to the invention, in the armed position

- Figure 2 is a plan view, in front elevation and in section, of the device according to the invention, in the released position;

- Figure 3 is an enlarged view in section, of a cartridge containing a dose of injectable product;

- Figure 4 is a view illustrating another method of fixing the cartridge on the device;

- Figure 5 is a sectional view illustrating the movement of the striker on the elastomer plug contained in the cartridge;

- Figure 6 is a perspective view of the clamp system to trap the striker rod;

- Figure 7 is a plan view, in front elevation and in section, of the device according to another embodiment of the invention, comprising a disengageable connecting member;

- Figure 8 is a perspective view of the disengageable connecting member;

- Figure 9 is a plan view, in front elevation and in section, of the device according to the invention;

- Figure 10 is a plan view, in front elevation and in section, of a cartridge according to a second embodiment; - Figure 11 is a plan view, in side elevation and in section, of a cartridge according to a second embodiment.

According to a preferred embodiment, the device which is the subject of the invention essentially comprises a body 1 extending in the form of a tube, in particular of cylindrical cross section, intended to receive an arming device 2 linked to a cap 3 , in particular knurled in order to improve its grip by the user, provided at one of the ends 4, 5 of said body. The cap is produced from a portion of tube, of section similar to that of the main body of said device, the diameter of which is however greater in order to allow a relative movement of rotation around the body and cooperates via 'An attachment device 6, in particular of the key type, to a ring 7, itself secured to a clamp 8. Said ring is fitted with play at the end of the body 1 and can rotate freely in the latter, its axial position in the tube being determined by a radial stop 9 at the wall of the tube and opening into a circular groove 10 formed on said ring 7 and positioned opposite the stop 9. The rotational movement from the cap 3 is transmitted by through the attachment device 6 to the ring.

Said ring 7 is further provided with a central recess 11 for the passage of a striker 12, free in axial translation and opening out inside said clamp 8. This clamp constitutes one of the links of the arming device . Of generally cylindrical shape, it is provided with a plurality of cutouts 13 oriented substantially parallel to the axis of the body so as to conform a plurality of flexible tabs 14. It is further provided to tap the internal bore 15 of said clamp 8 , so as to form imprints capable of being screwed around a threaded portion 16 provided on a rod 17 forming striker. The thread pitch is determined as a function of the chosen reduction ratio and the stiffness constant of a spring 18. The intensity of the striker can also be adjusted using a pre-adjustment of the crushing of the spring, the mter-turn space which can be adjusted by means of a wheel 46 moving on the rod 17 and in contact αe 18 or by means of a stack of washers arranged between the spring 18 and a ring 25. The turns of spring 18 are compressed by the relative movement of rotation between the cap 3 and the body 1.

According to an advantageous characteristic of the invention, the cap 3 comprises a safety device 47 which covers the rod of the striker 12. This safety device 47 is connected to the cap 3 by means of a joint 48 which allows a movement of rotation of the latter 47, between a locked position and an unlocked position of the striker rod 12. The rotation of the safety device 47 also makes it possible to act on the fastening member 6 between the cap 3 and the ring 7. Indeed, it is imperative that the user can arm the percussion device only when the safety device 47 covers the rod of the striker 12; this is why, when the safety device 47 is locked on the cap 3, it acts on the hooking member 6 so that the latter authorizes the transmission of the rotational movement between the cap 3 and the ring 7.

When the safety device 47 is unlocked, that is to say when it no longer covers the striker rod 12, it no longer acts on the fastening member 6 and the user cannot arm the device percussion. There is therefore a rod 17, forming a piston, inside said body 1, its length being chosen such that its end 19, not linked to said clamp 8, is flush with one of the front surfaces 4, 5 of the body 1 , when the arming device 2 is operational.

The peripheral envelope 20 of the clamp is enclosed by a spacer 21, also of section similar to that of the body, the outside diameter of which corresponds to the inside diameter of the body, so as to conform guide zones. Its axial position inside the body being limited on the one hand, at one of its ends 23, 24, by a pin 22 passing right through and radially the striker 12, and on the other hand its other end front constituting a bearing surface for a spring 43; the axial position of the spring and its other bearing surface being further limited for example by a ring 25 inserted in the body, integral with said rod 17 and immobilized axially optionally by a circlip 26, or by a practical shoulder on the rod.

In the cocking position, the user prints a relative rotational movement between the body 1 and the cap 3; as we have seen previously, the rotational movement of the cap is transmitted both to said ring 7 and to the clamp 8 integral with the latter; the few threads of said clamp 8 engaged with those of the rod make it possible to initiate the translational movement between the rod 17

(forming a screw) and the clamp 8 (forming a nut) and the relative approximation of these two parts. This translational movement compresses the turns of the spring 18 until the mter-turns space is reduced to the maximum. According to another embodiment, the coil spring can be replaced by a helical spring or by any other elastic device. In the disarming or triggering position, the user prints a slight push on the striker 12, the pin 22 projecting radially and in contact with one of the front faces 23, 24 of the spacer, transmits a relative movement of translation between the 'spacer 21 and the clamp 8, which releases the end of the latter from a conical bearing 27 provided at the bottom of the bore of said spacer 21. The thrust of the spring 18 combined with the flexibility of the legs of the clamp releases the respective threads previously engaged, thereby causing a translation movement, almost impulse of the entire rod.

According to another embodiment of the invention, there is interposed, between the cap 3 and the arming member secured to the clamp 8 contained in the body 1, a connecting member 38 which does not allow the relative rotational movement between these two pieces only in one direction of rotation. Indeed, to avoid any deterioration of the device and to simplify handling by the user, there is a disengageable connecting member 38 consisting mainly of two parts 39, 40 in particular of circular section. One of the parts 39 is integral with the cap 3, while the other 40 is linked to the clamp 8 and to the body 1 by means of a groove 44, each of the parts moreover has at their face in contact of a plurality of zones 41 in relief. These zones 41 have a profile capable of allowing on the one hand a relative sliding between the parts 39, and 40 according to a direction of rotation between the cap 3 and the body 1 and on the other hand to transmit the torque in the other direction of rotation of the cap 3 relative to the body 1.

Preferably, the zones 41 in relief are produced from a plurality of teeth, in particular with a triangular cross section. In order for the connecting member 38 to function, it is however advisable not to completely eliminate the movements of the parts 39 and 40 relative to the cap 3 and to the clamp 8; thus when the connecting member is active (disengaged), the parts 39, 40 must escape longitudinally relative to one another and these parts return to their gear position after removal of the torque; an elastic member 41, in particular of the spring type, is interposed in line with the external surface of one of the parts 39 or 40, at a guide portion 42, which compensates for the translational movements between the parts.

According to another characteristic of the invention, there is at the other end 5 of the body 1 of said device, a cartridge 28 by known means such as in particular by screwing, by clipping (socket, bayonet).

According to an advantageous characteristic of the invention, the cartridge 28 comprises two elements 49, 50:

- The first element 49 makes the container to contain the active ingredient and it is particularly obtained from a type I medical grade glass, since the container must contain injectable products;

the second element 50 is constituted by a plastic envelope which covers on said first element 49.

Advantageously, the plastic material used in the molding operation, that is to say covering, must be able to withstand a sterilization operation at high temperature (around 120 ° C), approved for pharmaceutical applications, does not not be sensitive to temperature differences in terms of its expansion, since the cartridges 28 are generally stored in an environment whose temperature is between 2 and 10 ° C. Furthermore, after overmolding on the first element 49, the plastic used is translucent, even transparent and can be tinted. For example, the product called "TPX" (polymethylpentene) will be chosen as plastic.

The first glass element 49, generally of substantially cylindrical shape, has at each end an orifice 29, 30. One of the orifices 30 has a diameter substantially equivalent to the diameter of the rod 17, while the other 29, of small diameter, in particular of the order of a few tenths of a millimeter, serves as a nozzle. The internal cavity of said cartridge is filled under vacuum with an active principle 31 and is optionally coated with a film 32 of material, compatible with the physicochemical properties of said product in order to minimize the adsorption phenomenon.

The cartridge 28 thus formed by the overmoulding of a plastic material on a first glass element 49, comprises at one of its ends, means 51 allowing the engagement and the joining of said cartridge on the nose of the device. injection.

Advantageously, the means 51 enabling engagement and securing are carried out during the overmolding operation by means of a plurality of lugs 52 projecting radially and arranged according to the diameter of said cartridge 28, these lugs cooperating with level of the bayonets provided at the end 53 of the injection device.

The other end 54 of said cartridge 28 is shaped into a flat surface intended to be applied against the surface of the skin of the user. The outlet port 31 household on this end 54 must be protected from possible contamination of the surrounding environment and for this purpose, there is a cap 55 provided in its center with an elastomer seal 56, in particular silicone.

According to another embodiment, a film covering the surface of the cartridge 28 is placed on the end 54.

This cap 55 is obtained by a plastic molding process, possibly similar to that composing the cartridge.

The cap 55 advantageously has side walls 57 which enclose the end of said cartridge 28, said walls 57 being provided at their ends with raised areas 58 allowing their clipping at the level of indentations 59 provided on the outer side walls of said cartridge 28, thereby ensuring the maintenance of the cap 55 on the cartridge.

The upper wall 60 of the cap 55 forms a gripping zone which allows the user to position the pins 52 of the cartridge 28 in line with the bayonets of the injection device and by means of a simple rotation movement, to block the pins 52 in the bayonets and allow, when the user continues to print on the cap 55 and therefore on the cartridge 28 which is integral with him this rotational movement after blocking of the pins 52, to separate the side walls 57 of the cap 55 from the imprints 59 of the cartridge 28, so as to put the injection device ready for use. According to a first variant, the elastomer seal 56 is obtained during a simultaneous operation of molding the cap 55.

According to a second variant, the elastomer seal 56 is attached and rises in force in an orifice 61 provided on the internal wall 62 of the cap 55.

According to another advantageous characteristic of the invention, provision is made to have in the thickness of the plastic overmolding of the cartridge 28 a plurality of lack of plastic material in order to produce lights 63 to improve visibility at the level of the first element 49 in glass. The cartridge 28 thus obtained is for single use and therefore disposable.

After filling, the opening 30 of the cartridge is closed with a cover 33 in order to guarantee satisfactory aseptic conditions. It is also planned to interpose between the dose of product contained in the cavity of the cartridge and the sealing cap, an elastomeric stopper 34 for closing the dose, the latter having to communicate to the liquid the pressure exerted by the piston of a striker.

According to an advantageous characteristic of the invention, provision is made for the striker piston to be pressed a few millimeters into the body of the cartridge so that the percussion force is directed and centered in the axis of the elastomer plug 34 to avoid any risk of the first glass element forming the cartridge 28 bursting.

According to another mode of use of the cartridge 28, it is empty and is filled by the user just before use. The outer envelope of said cartridge also has, on the one hand fixing means 35, 35 'to said body (no screw, pin ...), and on the other hand relief zones 36 for gripping it by the user. The front face corresponding to the nozzle optionally comprises a bowl 37 whose depth is variable but guarantees that the jet leaving the orifice of the nozzle has the time necessary for its hydrodynamic establishment before the subcutaneous, intradermal or intramuscular injection.

The invention as described above is very easy to use: there is no longer any sterilization or washing of the device, while guaranteeing increased safety for the user of by the absence of a needle and the impossibility of carrying out a reuse without having previously reloaded by a new dose in the device, the method of fixing the cartridge avoiding all the risks of bursting of the latter due to the absence of cylinder head. This invention is advantageously suitable for use by an individual user who does not have specific knowledge of subcutaneous, intradermal or intramuscular injections, on the one hand it reduces the risk of accidents, always possible with a means of needle injection and on the other hand, it eliminates the fear of being bitten as well as any risk of contamination. The use of this device also makes it possible to respect the chronobiology of the patient. This invention finds advantageous developments in the injection of a dose of small volume, which can reach in particular from 0.05 to 0.2 ml. It is of particular interest for the administration of drugs or vaccines in humans or animals. Mention will be made, among other products, of polypeptides or peptides, such as enzymes and very especially calcitonin, used for the prevention of bone loss and the treatment of osteoporosis or drugs against migraine. Other products, in in particular, polypeptides or peptides which can be administered by the device which is the subject of the invention, include hormones, such as insulin, somatostatism, growth hormone, coagulation factors, for example anti-hemophilic factors, plasma components, such as erythropoietic, anti-viral polypeptides, such as interferons, or immunomodulators, such as lymphokines. This device is also especially suitable for the administration of vaccine preparations.

It remains to be understood that the present invention is not limited to the exemplary embodiments described and shown above, but that it encompasses all variants thereof. Thus, the cartridges can be presented in front of the striker rod using a barrel or a magazine, they can also include the dose of the product to be injected.

Claims

1 - Device for injection by jet without needle, comprising a body (1) receiving at one (4) of its ends (4, 5) a cap (3) which can, thanks to a relative movement between these elements, cause an arming device (2), cooperating with a percussion member, characterized in that at the other end (5) of the body (1) of said device, there is a cartridge (28) comprising two elements (49, 50): the first element (49) makes the container to contain the active ingredient;

- The second element (50) consists of a plastic envelope which covers said first element (49).

2 - Injection device according to claim 1, characterized in that the first element (49) is obtained from a type I medical grade glass.

3 - Injection device according to claim 1, characterized in that the second element (50) is made of a plastic material having the following characteristics: withstand a sterilization operation at high temperature,

- be approved for pharmaceutical applications,

- be insensitive to temperature variations,

- be translucent, even transparent and possibly tinted.

4 - Injection device according to claim 1, characterized in that the first element (49), generally of substantially cylindrical shape, comprises at each end an orifice (29, 30), one (30) of the orifices having a diameter substantially equivalent to the diameter of a rod (17), while the other (29), of small diameter, in particular of the order of a few tenths of a millimeter, serves as a nozzle.

5 - Injection device according to any one of the preceding claims, characterized in that the cartridge (28) comprises at one of its ends, means (51) allowing the engagement and securing of said cartridge on the nose of the injection device.

6 - Injection device according to claim 5, characterized in that the means (51) enabling engagement and securing are carried out during the operation of covering the overmolding by means of a plurality of lugs ( 52) projecting radially and arranged along the diameter of said cartridge (28), these pins cooperating at the bayonets provided at the end (53) of the injection device.

7 - Injection device according to any one of the preceding claims, characterized in that the end (54) of the cartridge (28) is coated with a cap (55) provided in its center with an elastomer seal (56), in particular made of silicone.

8 - Injection device according to claim 7, characterized in that the cap (55) has side walls (57) which surround the end of said cartridge (28), said walls (57) being provided at their ends raised areas (58) allowing their clipping at the level of indentations (59) provided on the outer side walls of said cartridge (28), thereby ensuring the maintenance of the cap (55) on the cartridge.

9 - Injection device according to one of claims 7 or 8, characterized in that the upper wall (60) of cap (55) forms a gripping zone which allows the user to position the pins (52) of the cartridge (28) in line with the bayonets of the injection device.

10 - Injection device according to claim 7, characterized in that the elastomer seal (56) is obtained during a simultaneous operation of molding the cap (55).

11 - Injection device according to claim 7, characterized in that the elastomer seal (56) is attached and force-fitted into an orifice (61) provided on the internal wall (62) of the cap (55).

12 - Injection device according to any one of the preceding claims, characterized in that it comprises a plurality of lack of plastic, practical in the thickness of the plastic overmolding of the cartridge (28), in order to produce lights (63) to improve visibility at the first element (49).

13 - Injection device according to any one of the preceding claims, characterized in that the percussion member is pressed a few millimeters into the body of the cartridge.

14 - Device according to any one of the preceding claims, characterized in that the cap (3) comprises a safety device (47) which covers the rod of the striker (12).

15 - Device according to any one of the preceding claims, characterized in that it comprises a safety device (47), which is connected to the cap (3) via a joint (48) which allows movement of rotation of the latter (47), between a locked position and an unlocked position of the rod of the striker (12), the rotation of the safety device (47) also making it possible to act on the attachment member (6) between the cap (3) and the ring (7).